Patent Baristas

In following the status of the reexamination request on Pfizer’s Viagra (sildenafil citrate) patent (U.S. Pat. No. 6,469,012), we find that Pfizer has filed a response to the outstanding Nonfinal Office Action.

See the Nonfinal Office Action here.

To recap, Pfizer filed a patent infringement lawsuit against ICOS, Lilly ICOS, and Lilly in the United States District Court contending that the use, offering for sale, selling, manufacture, or importing into the United States of Cialis for the treatment of erectile dysfunction by any of the defendants infringes claim 24 of Pfizer’s U.S. Patent No. 6,469,012.

The USPTO subsequently ordered the reexamination of the Pfizer Patent (Reexam. C.N. 90/007,478) and in the first office action issued by the PTO, the Examiner rejected claim 24 of the Pfizer Patent.

Claim 24 reads:

A method of treating erectile dysfunction in a male human, comprising orally administering to a male human in need of such treatment an effective amount of a selective cGMP PDEv inhibitor, or a pharmaceutically acceptable salt thereof, of a pharmaceutical composition containing either entity.

This broad claim would cover treatment by any cGMP PDEv inhibitor (read: Cialis) and was rejected over the references Korenmann, 41 J. Am Geriatrics Soc. 363 (1993) and Yin et al., 10(6) Yunnan J. Traditional Chinese Medicine 13 (1989).

The Examiner rejected claim 24 on the basis that certain prior art rendered the claimed invention not new, and therefore unpatentable under 35 U.S.C. §102(b), and obvious and unpatentable under the judicially created doctrine of obviousness-type double patenting.

On September 15, 2005, the USPTO issued a second office action that rejected Pfizer’s arguments made in response to the first office action, reaffirmed the initial rejection of claim 24, and entered new grounds for rejecting claim 24. The second office action also maintained the obviousness-type double patenting rejection of the other claims.

Pfizer has now filed a Response arguing that the Examiner employed applied a one-way test of obviousness for claim 24 in finding obviousness-type double patenting over claim 1 of each of U.S. Pat. Nos. 6,534,511, 6,100,270 and 6,656,945, and that there is no double patenting under this test. They have argued that simply because an invention falls within a range disclosed by the prior art does not necessarily make it per se obvious. Both the genus and species may be patentable.

Pfizer also contends that the Patent Office had not met the burden of proof for establishing unpatentability stating that the reports relied upon by the Patent Office, as well as patentee’s own submissions, demonstrate there is no basis to conclude that pentoxifylline is a PDEV selective inhibitor or that it is effective in treating ED as required by claim 24.

Pfizer claims that the evidence the Patent Office relied upon is based on “junk science” that should not be accorded any weight (i.e., reports based on scientifically invalid methodology and lacking statistical significance, sometimes referred to as “junk science,” should not be relied upon. (Daubert v. Merrell Dow Pharm., Inc., 43 F.3d 1311,1322 (9th Cir. 1995)).

Regarding Claim 24 the Second Reexam Office Action states that “Bensky, Hsu, Chang & But and Yin individually teach the use of Yin Yang Huo in oral compositions to treat impotence.” The Patent Office also found that, although these references do not disclose that Yin Yang Huo is a selective cGMP PDEV inhibitor, “the scientific literature … establishes that the main ingredient of Yin Yang Huo-containing compositions, icariin, is a selective cGMP PDEV inhibitor.”

Pfizer now argues that there is no evidence that a PDEV selective inhibitor contained in Yin Yang Huo treats ED and that there is no evidence that icariin is the compound that treats ED – even assuming that anything in Yin Yang Huo treats ED.

We’ll keep you posted on further actions on this matter.

The U.S. Federal Trade Commission (FTC) is concerned about the recent use of anti-competitive drug patent deals in light of recent court rulings, which may spur drug companies to step up a practice of paying generic rivals to keep alternatives off the market.

The FTC has filed a series of lawsuits challenging patent settlement agreements between major drugmakers and their generic rivals. The agency contends that in some cases those settlements stifle competition because drugmakers are paying generics to stay out of the market.

Under federal law, drugmakers are allowed to seek U.S. Food and Drug Administration approval for generic versions of brand-name drugs before a drug’s patent expires. They must certify that the patent is invalid or will not be infringed by the new generic version.

In March, a federal appeals court overturned the FTC’s challenge to a patent settlement between Schering-Plough Corp. and Upsher-Smith Laboratories and American Home Products, now Wyeth. The FTC had issued a finding that the settlement illegally kept cheaper versions of Schering-Plough’s blood pressure drug K-Dur off the market but the appeals court said the companies were within their rights to use their patents to lock competitors out of the market.

The decision in Schering-Plough makes it very difficult (if not impossible) for parties challenging patent settlements to do so based on the terms of the settlement itself (i.e., the inclusion of a reverse payment). Plaintiffs will need to show that the generic company’s product did not infringe on a valid patent – a high hurdle to get over indeed.

Interestingly, under the applicable rules for appealing FTC administrative actions, respondents are entitled to choose which circuit court will hear their appeal. Bet you can imagine that anyone caught in similar administrative litigation would choose to bring its appeal in the Eleventh Circuit.

Currently, the FTC is seeking certiorari from the Supreme Court in Schering-Plough, and stated in its petition that the Eleventh Circuit’s decision “could seriously impede the Commission’s law enforcement efforts.”

In the FTC’s Petition for Certiorari from the Supreme Court in Schering-Plough, the questions presented are:

1. Whether an agreement between a pharmaceutical patent holder and a would-be generic competitor, in which the patent holder makes a substantial payment to the challenger for the purpose of delaying the challenger’s entry into the market, is an unreasonable restraint of trade.

2. Whether the court of appeals grossly misapplied the pertinent “substantial evidence” standard of review, by summarily rejecting the extensive factual findings of an expert federal agency regarding matters within its purview.

Download the FTC’s Petition for Certiorari here.

In November another federal appeals court upheld a lower court decision to throw out a similar case that private parties had filed against Barr Pharmaceuticals Inc. and AstraZeneca.

The patent settlement challenged in that case involved AstraZeneca’s Novaldex. Novaldex (tamoxifen citrate) is a drug sold by AstraZeneca that is used to treat breast cancer. The tamoxifen litigation involves an agreement between Imperial Chemical Industries, PLC (an affiliate of AstraZeneca) and Barr Laboratories to settle patent infringement litigation relating to Imperial’s patent for tamoxifen (the ‘516 patent).

Imperial sued Barr for infringement of the ‘516 patent, and the patent was found unenforceable after trial. Imperial appealed but Barr and Imperial reached a settlement agreement during the appeal and moved jointly to vacate the judgment of the district court. Under the agreement, Imperial licensed Barr to sell Novaldex, and Barr (which was the first ANDA filer) agreed not to pursue final approval of its ANDA prior to the expiration of the ‘516 patent.

It is worth noting that in subsequent litigation AstraZeneca obtained three decisions upholding its Tamoxifen patent in cases against other generic companies.

The Second Circuit court upheld the district court’s decision granting the defendants’ motion to dismiss the antitrust case. The Second Circuit panel emphasized that settlements are pro-competitive, and dismissed the views of the plaintiffs (and the FTC in Schering-Plough) that there is something inherently anticompetitive about reverse payments.

The court stated that because the Hatch-Waxman Act permitted generic companies to challenge patents without putting themselves at risk for significant damages, generic companies are in a strong position to demand a large premium in order to settle high-stakes cases. This is true even where the branded manufacturer may be reasonably confident of victory but wishes to avoid the litigation burden and uncertainty.

The plaintiffs in Tamoxifen have filed a petition for re-hearing en banc, and the FTC has submitted an amicus brief supporting the petition. In evaluating the petition for re-hearing, we expect the Second Circuit to focus, among other things, on (1) whether the “sham” standard used by the court was proper, and (2) whether dismissal at the pleading stage was appropriate.

We’ve been quite busy these days and so posting has been light as a result. Since I have a personal interest in getting my own workload reduced a little, I wanted to pass along that my firm is currently looking to hire on a few IP attorneys.

The Position:

Looking for a Patent Attorney with at least four years of mechanical and/or electrical patent prosecution experience. Applicants should have excellent leadership skills, academic credentials, writing and communication skills and be capable of independent and creative work.

The Place:

The Cincinnati office of Frost Brown Todd LLC is one of the largest regional law firms in the Midwest, one of the 100 largest law firms in the United States and a top-rated Midwest intellectual property practice. Not to mention the opportunity to work hand-in-hand with the Patent Baristas.

The Rest:

Send resume, transcripts and writing samples to Karen Laymance, Frost Brown Todd LLC, 2200 PNC Center, 201 East Fifth Street, Cincinnati, Ohio 45202 or by email to klaymance@fbtlaw.com.

The Food and Drug Administration (FDA) announced steps to advance the earliest phases of clinical research in the development of innovative medical treatments. This should make it easier for universities and small drug companies to test promising therapies in humans without having to pay the enormous amounts of expenditures normally required.

In guidance documents released today, Exploratory IND Studies and INDs – Approaches to Complying with CGMP During Phase 1, the FDA lays out specific approaches for researchers who are planning to conduct very early clinical studies in people and offers approaches for performing appropriate safety testing and producing small amounts of drugs safely. In line with the aims of FDA’s Critical Path Initiative to modernize the drug development process, these changes will enable U.S. medical researchers to evaluate much more efficiently the promise of scientific advances discovered in their laboratories.

Currently, the FDA says 9 of 10 experimental drugs fail in clinical testing that can cost companies millions. And many experimental drugs go untested in humans because the current system requires massive investments before the make-or-break stage of drug development.

The FDA approved only 20 new drugs last year and, from 2002 to 2004, newly approved drugs took an average of 8.5 years for approval. If the length of clinical trials were shaved by one-quarter, drug manufacturers would save $129 million while halving the time spent on clinical trials would lower drug development costs by 29 percent, saving drug companies $235 million.

In related draft guidance, INDs-Approaches to Complying with CGMP During Phase 1, the FDA outlines a suggested approach to complying with current good manufacturing practice (CGMP) requirements for drugs intended for use solely in phase 1 studies. With this new guidance and an accompanying regulation, FDA formally recognizes specific standards for the manufacture of small amounts of drug product for phase 1 studies and formulating an approach to cGMP compliance that is appropriate for the particular stage of drug development.

Direct Final Rule: Current Good Manufacturing Practice Regulation and Investigational New Drugs

Exploratory IND Studies

Federal Register

INDs — Approaches to Complying with CGMP During Phase 1

A Frost and Sullivan report out says that the expiration of the Polymerase Chain Reaction (PCR) patent (US Patent No. 4,683,202) is setting the stage for growth opportunities for nucleic acid purification and amplification technologies. Companies can now offer tests without developing a novel nucleic acid technology or paying a license fee.

The expiration of the PCR patent will be especially beneficial to academic research, given that they lack money but have lots of indentured grad students who can put together their own kits. The report also takes into account funding resources becoming ever scarcer causing researchers to look for alternatives for inexpensive sample preparation.

There is an intrinsic paradigm shift in research as the scientific community transitions from sequencing to functional genomics. This will lead to a greater need for consistently pure nucleic acid samples, which will drive demand for automated instrumentation products.

The demand for nucleic acid-based amplification kits is expected to continue over the next decade due to the completion of the human genome project and growing interest in molecular diagnostics.

The polymerase chain reaction is a test tube system for DNA replication that allows a “target” DNA sequence to be selectively amplified, or enriched, several million-fold in just a few hours. PCR uses just one indispensable enzyme – DNA polymerase – to amplify a specific fraction of the genome. DNA polymerase was first isolated from Thermus aquaticus in 1976. (Deoxyribonucleic acid polymerase from the extreme thermophile Thermus aquaticus by A Chien, D B Edgar, and J M Trela in Journal of Bacteriology 127 (3): 1550–1557.)

To perform a PCR reaction, a small quantity of the target DNA is added to a test tube with a buffered solution containing DNA polymerase, oligonucleotide primers, the four deoxynucleotide building blocks of DNA, and the cofactor MgCl2. As amplification proceeds, the DNA sequence between the primers doubles after each cycle. Following thirty such cycles, a theoretical amplification factor of one billion is attained.

The polymerase chain reaction was introduced at a conference in October 1985. Cetus rewarded the inventor, Kary Mullis, with a $10,000 bonus for his invention and later sold the patent for the PCR process to the pharmaceutical company Hoffmann-La Roche for $300 million.

More information on the report is available here.

Bruce MacEwen at Adam Smith, Esq. hosts a wonderful session of Blawg Review this week with a theme of Epiphany. We’re excited about anyone who knows that the 12 days of Christmas start the day after Christmas and end on Epiphany (there is that whole confusion over whether the Twelfth Night is on January 5th or 6th but we’ll leave that for another day).

Besides learning a little about Florentine painter Giotto di Bondone (c. 1267 – 1337), we learned of Patrick Lamb’s search for the perfect client service and the Top Ten Lies of Venture Capitalists by Guy Kawasaki – our favorite is “I liked your company, but my partners didn’t.” In other words, “no.” We also like his definition of blogger (n. Someone with nothing to say writing for someone with nothing to do).

Check out Blawg Review #39 for this week’s truth, grasped in an ordinary – and maybe somewhat melodramatic – moment.

One of the items I have trouble keeping up with is reporting on all the excellent law blogs that I come across. One recent addition to my RSS reader is Philip Brooks’ Patent Infringement Updates. This excellent blog provides insight into current events in patent infringement. There’s a whole category devoted to Patent Trolls (Peter Zura even called 2005 the Year of the Patent Troll on his 271 Patent blog).

For computer and internet intellectual property issues, we recommend following IPcentral.info, the Internet arm of the Center for the Study of Digital Property, which is a wholly-owned (and some times wholly disowned) part of The Progress and Freedom Foundation. They have an interesting article on why injunctions are necessary in the biotech and pharmaceutical areas.

Earlier, I asked if anyone could provide insight into the U.S. Patent Office’s proposed rules to limit the number of continuing, CIP and RCE applications that can be filed by patent applicants. Mr. Roy Marsh, a European Patent Attorney in Munich with Hoffmann Eitle, writes:

I surmise that the USPTO is envious of EPO success in managing its pendency periods, and so thinks it a good idea to borrow the EPO’s tools, to the extent that this is feasible.

I detect in USA an adversarial relationship between Exrs and Applicants that is not usual in Europe, and I venture to suggest it’s because of your presumption of validity. Here in Europe, nobody defers after grant to the work of Patent Office Examiners before grant, and validity after grant hangs on the preponderance of evidence. Because of that, examination on the merits is a chance to fashion, with help from the Examiner, a patent that has a sporting chance of withstanding heavier, competitor-inspired attacks on validity after issue.

This relationship might explain why European patent attorneys start with claim sets in which the dependent claims are genuine positions of enhanced patentability, yet have no expectation of being unfairly restricted to those claims by the 3-member Examining Division.

This might also explain why only 1% of EPO Exrs have resigned within their first year, but 30% in the USPTO. As an Examiner, you get more respect in the EPO.

Looking at a typical patent family list, one is usually struck by the skewed distribution, geographically. One finds typically 10 to 20 USPTO publications but only one or two publications for each other jurisdiction in the ROW. Something special about the USA is causing these distributions. Even if the value of any single non-US patent were as high as that of a US patent, I cannot imagine us in Europe getting to the numbers of patent publications I regularly see as the US component of a patent family.

Any Patent Office has to serve the public, not just its Applicant community, with the public policy objective of nurturing the tender young shoots of innovation. Helping youngsters clear their way through the patent thickets of the established market leaders is going to foster innovation, isn’t it?

Of course, USPTO Rules on their own aren’t going to change the numbers on the patent families. Does anybody want less US items on a patent family list? If so, then they will need to convince the US of the need for deeper changes, in the US patent system.

Let us know your comments on the Proposed Rules.